HEAD AND SHOULDERS CONDITIONER SMOOTH AND SILKY- pyrithione zinc lotion

Head and Shoulders Conditioner by

Drug Labeling and Warnings

Head and Shoulders Conditioner by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione zinc 0.5%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• condition worsens or does not improve after regular use of this product as directed.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for best results use at least twice a week or as directed by a doctor.
• apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Inactive ingredients

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone.

Questions (or comments)?

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 315 mL Tube Label

head &

shoulders ®

pyrithione zinc dandruff conditioner

smooth & silky
HAIR & SCALP
CONDITIONER

24 hour frizz control from root to tip

10.6 FL OZ (315 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS CONDITIONER  SMOOTH AND SILKY
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
GLUTAMIC ACID (UNII: 3KX376GY7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-103-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2016	12/22/2019
2	NDC: 69423-103-68	680 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2016	09/08/2019
3	NDC: 69423-103-90	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2016
4	NDC: 69423-103-65	650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/11/2017	10/03/2020
5	NDC: 69423-103-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/09/2018	10/31/2020
6	NDC: 69423-103-10	10 mL in 1 POUCH; Type 0: Not a Combination Product	11/10/2017
7	NDC: 69423-103-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2018	07/20/2020
8	NDC: 69423-103-61	610 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/29/2018
9	NDC: 69423-103-31	315 mL in 1 TUBE; Type 0: Not a Combination Product	11/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/10/2016

Labeler - The Procter & Gamble Manufacturing Company (004238200)